(396 days)
Not Found
No
The description focuses on the mechanical function of a peristaltic pump tube set and its interaction with a pharmacy pump for fluid transfer. There is no mention of AI/ML algorithms for decision-making, analysis, or control. The barcode is used for basic setup information, not complex data processing.
No.
Explanation: The device is designed for repeatable drug dosage distribution and fluid transfer in pharmacy settings, not for direct patient contact or treatment of a disease or condition. It facilitates the preparation of medications, which is a step prior to administration by a therapeutic device.
No
Explanation: The device is a sterile tube set and pump system designed for transferring fluids, specifically for repeatable drug dosage distribution in healthcare environments. Its function is to move drugs from one container to another, not to diagnose a condition or disease.
No
The device description clearly details physical components like plastic tubing, silicone tubes, and a plastic cassette, indicating it is a hardware device, not software-only.
Based on the provided information, the Pronto Pump Tube Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution in healthcare environments." It's used to transfer fluids (drugs) from one container to another. This is a fluid handling and administration function, not a diagnostic one.
- Device Description: The description details a tube set for a peristaltic pump used to move liquids. It focuses on the mechanical aspects of fluid transfer.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Target User and Setting: The device is used by pharmacists and pharmacy technicians in hospital and compounding pharmacies for preparing medications. This is a pharmaceutical preparation setting, not a diagnostic testing setting.
- Performance Studies: The performance studies focus on aspects like volume accuracy, flow rate, sterilization, packaging, and biocompatibility – all relevant to a fluid transfer device for drug preparation, but not to an IVD.
In summary, the Pronto Pump Tube Set is a medical device used for the preparation and transfer of medications, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The ProntoPump Sterile Tube Sets are fluid transfer tube sets used in conjunction with the ProntoPump pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
Product codes (comma separated list FDA assigned to the subject device)
LHI, NEP
Device Description
The ProntoPump sterile tube set is a single channel tube set for use with the ProntoPump pharmacy pump. It consists of clear plastic tubing connected to a silicone tube that functions as a peristaltic pumping chamber. Peristaltic pumps function by a roller compressing the pump tubing and rolling along the length of the tube, squeezing the fluid inside the tube from one end to the other. It has a plastic cassette that holds the pumping chamber in place for insertion into the ProntoPump, which provides the rollers that the force the fluid to move. The proximal and distal ends of the PVC tubing have connectors for various devices and containers. Using the ProntoPump, the tube set is used to deliver specified volumes of liquid into a final dosing container in hospital pharmacies or compounding pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
The cassette is non-fluid-contact and helps hold the tubing in place for loading. It has a machine-readable barcode that can be read by the pharmacy pump. The barcode includes information about the particular tube set item number, lot number, and expiration date, which is used by pharmacy pump to facilitate set up of the tubing.
The tube set is intended to be used by trained healthcare personnel, and is not intended to be used for direct patient contact. Tube sets are packaged individually in a peel pouch and sterilized by radiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not intended for patient contact
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Customers for the tube sets are ProntoPump pharmacy pump users, including hospital and home care pharmacist and pharmacy technicians. These tube sets are used by trained personnel, and do not have direct contact with any patient. This product is used by Pharmacists and Pharmacy technicians both inside and outside of flow hoods.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
- ISO 8536-4:2019, Infusion equipment for-medical use- Part 4: Infusion . sets for single use, gravity feed.
- ASTM D4169-16:2016 Standard Practice for Performance Testing of . Shipping Containers and Systems
- ISO 80369-7:2016 Small-bore connectors for liguids and gases in . healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility:
- ISO 10993-1:2018 Biological evaluation of medical .
- devices Part 1: Evaluation and testing within a risk management . process
- USP 788, Particulate Matter in Injections .
Sterilization and Packaging:
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices . - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices -. Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 11137-1:2006 Sterilization of health care products Radiation -. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- . ISO 11137-2:2013 - Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose
Clinical or Animal Testing: N/A - No animal or clinical testing.
Key Results: The technological and performance differences between the devices have been analyzed and it has been concluded no new issues of safety and effectiveness are presented in the new device compared to the predicate device. The results of the bench testing conducted demonstrate the subject device is substantially equivalent to the predicate device in the intended use, indications for use and functionality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volume Accuracy: +/- 5% from 1.0 mL to 5.0 mL; +/- 4% above 5 mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
May 4, 2021
IPAX, Inc Jeff Baldwin CEO 2700 S Raritan St Englewood, Colorado 80110
Re: K200893
Trade/Device Name: ProntoPump Sterile Tube Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI, NEP Dated: April 2, 2021 Received: April 5, 2021
Dear Jeff Baldwin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200893
Device Name Pronto Pump Sterile Tube Set
Indications for Use (Describe)
The Pronto Pump Tube Set is a part of the Pronto Pump System. This tube set provides peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution in healthcare environments. The Pronto Pump Tube set provides the fluid path way and pumping mechanism for the pump system.
The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510(K) Summary K200893 | |
|---|---|
| Submitted by: | IPAX, INC. |
| 2700 S Raritan St | |
| Englewood, CO 80110 | |
| Registration Number: 1720734 | |
| Preparation date: | April 23, 2021 |
| Contact person: | Jeff Baldwin, CEO |
| Telephone number: | 303-975-2444 x 630 |
| Fax number: | N/A |
| E-mail Address: | jeffb@ipaxinc.com |
| Manufacturing Site Address: | IPAX, INC. |
| 2700 S Raritan St | |
| Englewood, CO 80110 | |
| Device Trade or Proprietary Name: | ProntoPump Sterile Tube Set |
| Common Name: | Set, I.V. Fluid Transfer |
| Product code: | LHI |
| Secondary Product Code: | NEP System/Device, Pharmacy Compounding |
| Regulatory Class: | Class II |
Regulation number: 21 CFR 880.5440 Intravascular administration set
Classification Panel: General Hospital
Model number: 3003852 Sterile Tube Set, Universal Spike – Luer Lock 3003854 Sterile Tube Set, Luer Lock to Luer Lock
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| Predicate Device: | K062909 Repeater Pump II Tube Sets |
|---|---|
| Common Name : | Set, I.V. Fluid Transfer |
| Regulation Number: | 21 CFR § 880.5440 Intravascular administration set, |
| Product Code: | LHI |
Device Description:
The ProntoPump sterile tube set is a single channel tube set for use with the ProntoPump pharmacy pump. It consists of clear plastic tubing connected to a silicone tube that functions as a peristaltic pumping chamber. Peristaltic pumps function by a roller compressing the pump tubing and rolling along the length of the tube, squeezing the fluid inside the tube from one end to the other. It has a plastic cassette that holds the pumping chamber in place for insertion into the ProntoPump, which provides the rollers that the force the fluid to move. The proximal and distal ends of the PVC tubing have connectors for various devices and containers. Using the ProntoPump, the tube set is used to deliver specified volumes of liquid into a final dosing container in hospital pharmacies or compounding pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
The cassette is non-fluid-contact and helps hold the tubing in place for loading. It has a machine-readable barcode that can be read by the pharmacy pump. The barcode includes information about the particular tube set item number, lot number, and expiration date, which is used by pharmacy pump to facilitate set up of the tubing.
The tube set is intended to be used by trained healthcare personnel, and is not intended to be used for direct patient contact. Tube sets are packaged individually in a peel pouch and sterilized by radiation.
Indications for Use
The ProntoPump Sterile Tube Sets are fluid transfer tube sets used in conjunction with the ProntoPump pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.
The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.
Comparison of Technological Characteristics with The Predicate Device
The ProntoPump sterile tube set has the same indications for use (to provide a fluid path for the dispensing of fluids using a pharmacy pump), and substantially the same tubing and connections (PVC tubing, ABS spike, ABS fittings) as the predicate device. The tube set uses a silicone tubing to provide peristaltic pump driven fluid transfer, while the predicate device used a high speed syringe pump
5
to provide fluid transfer. Both devices are provided as sterile, nonpyrogenic, individually packaged devices to be used with their respective pharmacy pumps.
| Feature | ProntoPump
Sterile Tube Set
(K200893) | Repeater
Pump II Tube
Set
(K062909) | Discussion/
Justification |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | The ProntoPump
Sterile Tube Sets are
fluid transfer tube
sets used in
conjunction with the
ProntoPump
pharmacy pump in
hospital and
compounding
pharmacies to
provide a pathway
through which fluid is
transferred from one
source container into
another suitable
container.
The device is for use
with IV bags,
syringes, elastomeric
infusers, and other
drug administration
containers. Sets are
sold sterile. | The Repeater Pump II
tube sets are fluid
transfer tube sets used
in conjunction with the
Repeater Pump II
pharmacy pump in
hospital and
compounding
pharmacies to provide a
pathway through which
fluid is transferred from
one source container
into another suitable
container. | Same |
| Intended Use | The ProntoPump
Sterile Tube Sets
are fluid transfer
tube sets used in
conjunction with the
ProntoPump
pharmacy pump in
hospital and
compounding
pharmacies to
provide a pathway
through which fluid is
transferred from one
source container into | The Repeater Pump
II tube sets are fluid
transfer tube sets
used in conjunction
with the ProntoPump
pharmacy pump in
hospital and
compounding
pharmacies to
provide a pathway
through which fluid is
transferred from one
source container into
another suitable | Same |
| Feature | ProntoPump
Sterile Tube Set
(K200893) | Repeater
Pump II Tube
Set
(K062909) | Discussion/
Justification |
| | another suitable
container. | container. | |
| Usage | Single use. Rx Only | Single Use. Rx Only | Same |
| Target
Population | Customers for the
tube sets are
ProntoPump
pharmacy pump
users, including
hospital and home
care pharmacist and
pharmacy
technicians. These
tube sets are used
by trained personnel,
and do not have
direct contact with
any patient. | Customers for the
tube sets are Baxa
Repeater Pump 2™
pump users, including
hospital and home
care pharmacist and
pharmacy
technicians. These
tube sets are used by
trained personnel,
and do not have
direct contact with
any patient. | Same |
| Anatomical | Not intended for
patient contact | Not intended for
patient contact | Same |
| Where Used | This product is used
by Pharmacists and
Pharmacy
technicians both
inside and outside of
flow hoods | This product is used
by Pharmacists and
Pharmacy
technicians both
inside and outside of
flow hoods | Same |
| Connections | Luer fittings, spikes
for IV bags, and
other standard IV, or
oral/ topical
connections.
Different sets will
have different
connections
depending on the
source and final
containers. | Luer fittings, spikes
for IV bags, and other
standard IV, or oral/
topical connections.
Different sets will
have different
connections
depending on the
source and final
containers. | Same |
| Feature | ProntoPump
Sterile Tube Set
(K200893) | Repeater
Pump II Tube
Set
(K062909) | Discussion/
Justification |
| Biocompatibility | ISO 10993-1,
Externally
Communicating,
Indirect | ISO 10993-1,
Externally
Communicating,
Indirect | Same |
| Inlet and
Outlet
Materials | Polyvinyl Chloride
(PVC): tubing with no
Di (2-ethylhexyl)
phthalate (DEHP)
added. | PVC tubing with no
DEHP added. | Same |
| Pumping
Mechanism | Uses a silicone tube
to provide peristaltic
pumping. | Uses a custom molded
syringe as a pumping
chamber. | Both methods achieve
the intended use of
transferring fluid from a
source container into
another container safely
and effectively. |
| Pumping
Chamber
Material | Medical grade
platinum cured
Silicone tubing | Clear plastic cylinder
containing a maximum
of 10 mL, non-latex
rubber piston, and a
non-latex rubber valve
to control direction of
flow. | Different:
The predicate device
uses a high-speed
syringe pump to transfer
fluids from a source
container into another
suitable container. The
ProntoPump uses a
silicone tube to provide
a peristaltic pumping
action to transfer into
another suitable
container. The methods
of transfer are
substantially equivalent
in terms of safety and
effectiveness of
achieving the intended
use |
| Spike Material | Acrylonitrile
Butadiene Styrene
(ABS) | ABS | Same |
| Luer
Connector
Materials | ABS | ABS | Same |
| Sterilization | Sterilized by Gamma
radiation ( $10 ^ -6$ ) | Sterilized by Gamma
radiation ( $10 ^ -6$ ) | |
| Feature | ProntoPump
Sterile Tube Set
(K200893) | Repeater
Pump II Tube
Set
(K062909) | Discussion/
Justification |
| Tube set
maximum
usage | Labelled for 40 L
maximum use | Labelled for 200 L
maximum use | Different
Sterile sets in critical
care pharmacies are
only used for 24 hours,
and most doses are
below 250 mL, the 24
hour limit is identified in
the ProntoPump Sterile
Tube Set Instructions
for Use.
The 40L limit will meet
the needs of almost all
users. The 40L limit is
identified in the
ProntoPump device
[510(k) exempt]
instructions for use |
| Minimum Flow
Rate at Top
Speed | At least 21 mL /s at
top speed | At least 11 mL /s | Different
Most doses in critical
care pharmacies are
below 250 mL, and the
higher flow rate of the
predicate device does
not provide significant
value to the user. The
flow rate of filling the
dose container has no
known impact on the
safety or efficacy of the
dose to the patient. |
| Feature | ProntoPump Sterile Tube Set (K200893) | Repeater Pump II Tube Set (K062909) | Discussion/Justification |
| Volume Accuracy | +/- 5% from 1.0 mL to 5.0 mL
+/- 4% above 5 mL | labelled as
+/1 0.02 mL from 0.2 ml to 2.0 mL
+/- 1% above 2.0 mL | Different
The predicate device used a fixed sized, high speed syringe pump to achieve the stated accuracy of the volume transferred from source container to the final container.
The ProntoPump tube sets use the silicone tubing in conjunction with the ProntoPump pharmacy pump to achieve the stated accuracy of the volume transferred from source container to the final container.
Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container have substantially equivalent safety |
Comparison of Technological Characteristics with the Predicate
6
7
8
9
10
Differences Compared to Predicate Device / Substantial Equivalence Discussion
The devices are similar in intended use, function, sterility, and packaging. The most notable physical difference is the predicate device uses a custom molded syringe as a pumping chamber. The ProntoPump sterile tube set uses a silicone tube to provide peristaltic pumping. Both methods achieve the intended use safely and effectively.
While the predicate device is labelled for deliveries as small as 0.2 mL, it is not for use on syringes smaller than 3mL. The ProntoPump sterile tube set is labelled for use down to 1.0 mL. This is since for practical reasons that is the smallest delivery users would be likely to put into a 3 mL syringe.
The volume accuracy claim of the predicate device was +/- 0.02 mL from 0.2 mL to 2.0 mL, and +/- 1% above 2.0 mL. The ProntoPump Tube Set provides accuracy of +/- 5% from 1.0 mL to 5.0 mL and +/- 4% above 5 mL. Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container is substantially equivalent in terms of safety and effectiveness.
The technological and performance differences between the devices have been analyzed and it has been concluded no new issues of safety and effectiveness are presented in the new device compared to the predicate device. The results of the bench testing conducted demonstrate the subject device is substantially equivalent to the predicate device in the intended use, indications for use and functionality.
Summary of Performance Testing
Bench Testing
- ISO 8536-4:2019, Infusion equipment for-medical use- Part 4: Infusion . sets for single use, gravity feed.
- ASTM D4169-16:2016 Standard Practice for Performance Testing of . Shipping Containers and Systems
- ISO 80369-7:2016 Small-bore connectors for liguids and gases in . healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility
- ISO 10993-1:2018 Biological evaluation of medical .
- devices Part 1: Evaluation and testing within a risk management . process
11
- USP 788, Particulate Matter in Injections .
Sterilization and Packaging
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices . - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices -. Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 11137-1:2006 Sterilization of health care products Radiation -. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- . ISO 11137-2:2013 - Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose
Clinical or Animal Testing
N/A - No animal or clinical testing.
Substantial Equivalence Conclusion:
Based on the indication for use, the technological and performance characteristics, and results of performance testing, the subject device Pronto Pump Sterile tube sets have been demonstrated to be substantially equivalent to the legally marketed predicate device, K062909.